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Azelastine Hydrochloride

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SHARQIYA LIFITINGS

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53

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31-12-2016

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per 500

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Description

Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using TLC silica gel F254 plate (Merck silica gel 60 F254plates are suitable) and a mixture of 1 volume of 18M ammonia, 40 volumes of ethanol (96%) and 60 volumes of toluene as the mobile phase. Apply separately to the plate 10 Âµl of each of four solutions in a mixture of equal volumes of dichloromethaneand methanol containing (1) 5.0% w/v and (2) 0.0050% w/v of the substance being examined, (3) 0.0050% w/v of 4-chlorobenzylphthalazinone BPCRS and (4) 0.0050% w/v of 1-methylazepan-4-one hydrochloride BPCRS. After removal of the plate, heat at 115 for 1 hour, cool and examine under ultraviolet light (254 nm). Spray the plate with sodium iodobismuthate solution followed by a 5% w/v solution of sodium nitrite and re-examine. In the chromatogram obtained with solution (1) any spot corresponding to either of the two named impurities is not more intense than the corresponding spot in the chromatograms obtained with solution (3) and (4), respectively (0.1% of each) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.1%). Disregard any spot remaining on the line of application.
Loss on drying
When dried to constant weight at 100 to 105 loses not more than 1% of its weight. Use 1 g.
Assay
Dissolve 0.3 g in 5 ml of anhydrous formic acid, add 30 ml of acetic anhydride and carry out Method I for non-aqueous titration, Appendix VIII A, determining the end-point potentiometrically. Each ml of 0.1M perchloric acid VS is equivalent to 41.84 mg of C22H24ClN3O, HCl.
Storage
Azelastine Hydrochloride should be kept in an airtight container and protected from light.
Action and use
Prophylaxis of allergic conditions.

Azelastine hydrochloride (HCl), fluticasone propionate 137mcg/50mcg; per 0.137mL metered nasal spray; aqueous suspension.
Definition
Azelastine Hydrochloride is (RS)-4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one hydrochloride. It contains not less than 98.5% and not more than 101.0% of C22H24ClN3O, HCl, calculated with reference to the dried substance.
Characteristics
A white, crystalline powder.
Slightly soluble in water ; soluble in absolute ethanol ; practically insoluble in ether , in n-hexane and in toluene.
Identification
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of azelastine hydrochloride(RS 018).
B. Yields reaction A characteristic of chlorides, Appendix VI.
C. Complies with the test for Optical rotation.

More Details

Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using TLC silica gel F254 plate (Merck silica gel 60 F254plates are suitable) and a mixture of 1 volume of 18M ammonia, 40 volumes of ethanol (96%) and 60 volumes of toluene as the mobile phase. Apply separately to the plate 10 Âµl of each of four solutions in a mixture of equal volumes of dichloromethaneand methanol containing (1) 5.0% w/v and (2) 0.0050% w/v of the substance being examined, (3) 0.0050% w/v of 4-chlorobenzylphthalazinone BPCRS and (4) 0.0050% w/v of 1-methylazepan-4-one hydrochloride BPCRS. After removal of the plate, heat at 115 for 1 hour, cool and examine under ultraviolet light (254 nm). Spray the plate with sodium iodobismuthate solution followed by a 5% w/v solution of sodium nitrite and re-examine. In the chromatogram obtained with solution (1) any spot corresponding to either of the two named impurities is not more intense than the corresponding spot in the chromatograms obtained with solution (3) and (4), respectively (0.1% of each) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.1%). Disregard any spot remaining on the line of application.
Loss on drying
When dried to constant weight at 100 to 105 loses not more than 1% of its weight. Use 1 g.
Assay
Dissolve 0.3 g in 5 ml of anhydrous formic acid, add 30 ml of acetic anhydride and carry out Method I for non-aqueous titration, Appendix VIII A, determining the end-point potentiometrically. Each ml of 0.1M perchloric acid VS is equivalent to 41.84 mg of C22H24ClN3O, HCl.
Storage
Azelastine Hydrochloride should be kept in an airtight container and protected from light.
Action and use
Prophylaxis of allergic conditions.

Azelastine hydrochloride (HCl), fluticasone propionate 137mcg/50mcg; per 0.137mL metered nasal spray; aqueous suspension.
Definition
Azelastine Hydrochloride is (RS)-4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one hydrochloride. It contains not less than 98.5% and not more than 101.0% of C22H24ClN3O, HCl, calculated with reference to the dried substance.
Characteristics
A white, crystalline powder.
Slightly soluble in water ; soluble in absolute ethanol ; practically insoluble in ether , in n-hexane and in toluene.
Identification
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of azelastine hydrochloride(RS 018).
B. Yields reaction A characteristic of chlorides, Appendix VI.
C. Complies with the test for Optical rotation.